If the recent Science Board report on science within the Agency wasn't enough and you needed more evidence of the urgent need for better IT infrastructure, staffing and other resources for FDA, the Wall Street Journal released this bombshell this morning. Click here to read.
Baxter's recalled generic Heparin may be linked to API manufactured by a Chinese manufacturer that was "supposed to have been inspected." What happened? Human error and inadequate IT, the Journal reports, so a pre-approval inspection was never performed (although the Cherry Hill, N.J. plant where the finished version of the drug is packaged had been inspected).
Some suggestions? Have the Agency focus only on drugs and build up its data management capabilities and give it the funding ( a lot more funding) to hire more inspectors. As API manufacturing has stepped up in China and India, FDA has become the de facto police for API and drug manufacturing around the world, and it simply doesn't have the resources to do this job properly. How could it? Have you read the FDA budget allocations?
Dr. Janet Woodcock touched on the issue of resources lightly in this recent interview with Emil Ciurczak.
Schaumberg, Ill.-based heparin manufacturer APP was quick to jump in and announce production increases. As the WSJ blog pointed out, that company also sources its API from a Chinese manufacturer, although a spokesperson says the company has not heard of any adverse reactions.
Heparin is a critical and widely used drug. Regardless of the outcome of this particular story, it is sure to heighten scrutiny of foreign API plant inspections. Perhaps it will also prompt more discussions in Washington about increasing the funding and staffing to allow more of those inspections to take place, and establishing the IT needed to track inspection data and information on adverse reactions. What do you think?
AMS

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Comments

Submitted by Girish Malhotra on Thu, 02/14/2008 - 14:50

<p>The recent fiasco of Heparin being sold by Baxter International is going to lay the blame of FDA (lack of inspection) and companies from China and India for making poor quality product and shipping it to US sellers. This is very myopic thinking.</p>
<p>Companies in EU or US who are importing active pharmaceutical ingredients (API) from China and India very well know which manufacturing facilities in these two countries have been inspected by USFDA and EU regulators. If they are importing API and formulated drugs from un-inspected facilities, then the blame of non-compliance has to be squarely put on the companies selling these products in EU and US.</p>
<p>It is well known that the regulatory agencies do not have sufficient staff to be inspecting every facility. With that being the case, the companies that are selling the pharmaceuticals have shrugged their â€œcorporate responsibilityâ€? of selling products that have to meet regulatory standards.</p>
<p>We saw the case of melamine being incorporated in the dog food to enhance the superficial nitrogen content to give the analytical people the â€œgood feelingâ€? of meeting the necessary standards. No one has studied the toxicity of a substituted non-food product on human and animal health. Same thing happened with toothpaste.</p>
<p>Baxter International did not set up the proper protocol with their Chinese suppliers. I am sure they had set up the standards that have to be strictly met. However, there were sufficient laxities in the spec and/or the protocol for slightly off-spec API to pass through. I would not be surprised that the API met every spec but was slightly off spec that if not carefully reviewed would meet the set specifications.</p>
<p>Having manufactured products that have dual use i.e. food grade and non-food grade, I can speculate and speak from experience. In the case of Heparin, the API could not be reworked to meet the specs. Since it was marginally off specification and might meet the spec if overlooked must have been the case for the lots imported by Baxter International.</p>
<p>Press, legislators, and consumers have to look at the facts before they jump to conclusion that FDA is not doing its job and companies in China and India are bad. Any company anywhere if gets a similar opportunity will try to use a short cut and reduce rework, which cuts into profits.</p>
<p>Let us think rationally and understand the facts. Right or wrong, the seller has to be blamed no matter what the facts are. They did not live up to their responsibility.</p>
<p>Girish Malhotra</p>

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